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Aziyo Biologics (AZYO)

Aziyo Biologics is a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. Since its founding in 2015, the Company has created a portfolio of commercial-stage products used in cardiovascular, orthopedic, and reconstructive specialties.

Company profile

AZYO stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

10 May 22
15 Aug 22
31 Dec 22
Quarter (USD) Mar 22 Dec 21 Sep 21 Jun 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 22.18M 22.18M 22.18M 22.18M 22.18M 22.18M
Cash burn (monthly) 2.75M 693.83K 2.71M 2.51M 2.45M 1.47M
Cash used (since last report) 12.36M 3.12M 12.19M 11.27M 11.01M 6.6M
Cash remaining 9.81M 19.06M 9.99M 10.91M 11.16M 15.58M
Runway (months of cash) 3.6 27.5 3.7 4.4 4.6 10.6

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
21 Jun 22 C Randal Mills Stock Option Class A Common Stock Grant Acquire A No No 6.39 182,511 1.17M 182,511
21 Jun 22 C Randal Mills Stock Option Class A Common Stock Grant Acquire A No No 6.39 273,767 1.75M 273,767
7 Jun 22 Maybelle Jordan Stock Option Class A Common Stock Grant Acquire A No No 6.28 22,090 138.73K 22,090
7 Jun 22 Brigid Makes Stock Option Class A Common Stock Grant Acquire A No No 6.28 22,090 138.73K 22,090
7 Jun 22 C Randal Mills Stock Option Class A Common Stock Grant Acquire A No No 6.28 22,090 138.73K 22,090
8 Mar 22 Peter G Edwards RSU Class A Common Stock Grant Acquire A No No 0 4,625 0 4,625
8 Mar 22 Peter G Edwards RSU Class A Common Stock Grant Acquire A No No 0 8,700 0 8,700
8 Mar 22 Peter G Edwards Stock Option Class A Common Stock Grant Acquire A No No 5.08 31,000 157.48K 31,000
60.2% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 14 9 +55.6%
Opened positions 6 1 +500.0%
Closed positions 1 9 -88.9%
Increased positions 0 2 EXIT
Reduced positions 3 3
13F shares Current Prev Q Change
Total value 31.9M 31.65M +0.8%
Total shares 5.61M 6.94M -19.3%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners Shares Value Change
Highcape Partners 4.86M $27.47M 0.0%
Brown Advisory 230.67K $1.37M 0.0%
Perkins Capital Management 227.73K $1.36M 0.0%
Platinum Investment Management 188.18K $1.12M -3.9%
Vanguard 55.57K $331K NEW
Bridgeway Capital Management 24.9K $148K NEW
BLK Blackrock 6.38K $38K -4.7%
BCS Barclays 3.03K $18K NEW
MS Morgan Stanley 2.88K $17K NEW
UBS UBS Group AG - Registered Shares 1.56K $9K NEW
Largest transactions Shares Bought/sold Change
Birchview Capital 0 -1.42M EXIT
Vanguard 55.57K +55.57K NEW
Bridgeway Capital Management 24.9K +24.9K NEW
Platinum Investment Management 188.18K -7.63K -3.9%
BCS Barclays 3.03K +3.03K NEW
MS Morgan Stanley 2.88K +2.88K NEW
UBS UBS Group AG - Registered Shares 1.56K +1.56K NEW
Tower Research Capital 1.2K +1.2K NEW
BLK Blackrock 6.38K -315 -4.7%
BAC Bank Of America 12 -51 -81.0%

Financial report summary

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Competition
StrykerNuvasiveAbbvie
Risks
  • Our long-term growth depends on our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings.
  • Our revenue and profitability could be materially and adversely affected if we fail to maintain our relationships with our existing contract manufacturing customers and enter into agreements with new contract manufacturing customers, or if existing contract manufacturing customers reduce purchases of our products. Our relationships with these customers also subject us to certain risks.
  • We plan to expand our direct sales force coinciding with new product launches, and if we are unable to successfully expand, manage and maintain our direct sales force, we may not be able to generate greater market share and revenue growth.
  • We are working to grow our direct sales force, which may result in higher fixed costs and may slow our ability to reduce costs in the face of a sudden decline in demand for our products.
  • We have incurred operating losses since our inception, expect to continue to incur significant expenses and operating losses in the future, and may not be able to achieve or sustain profitability.
  • Our business has been, and may continue to be, adversely affected by the outbreak of the novel strain of coronavirus disease, COVID-19, and may be adversely affected by any future pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide.
  • Adverse changes in general domestic and global economic conditions and instability and disruption of credit markets, including as a result of the current COVID-19 pandemic or any other outbreak of an infectious disease, could adversely affect our business, financial condition, results of operations and liquidity.
  • Our future growth depends on physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products.
  • Our success depends on the continued and future acceptance of our products by the medical community.
  • Unfavorable results from any of our pre-clinical or clinical studies, comparative effectiveness, economic or other studies, or from similar studies conducted by others, may negatively affect the use or adoption of our products by physicians, hospitals and payors, which could have a negative impact on the market acceptance of our products and their profitability.
  • We will need to continue to expand our organization and managing growth may be more difficult than we expect.
  • We regularly evaluate opportunities to make acquisitions of, investments in, and licenses or other commercial arrangements involving, other companies or technologies, and to enter into other strategic transactions. These transactions entail significant risks.
  • New lines of business and new products and services may subject us to additional risks.
  • We face significant and continuing competition from other companies, some of which have longer operating histories, more established products and/or greater resources than we do, which could adversely affect our business, financial condition and results of operations.
  • Pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability.
  • The processing of human and porcine tissue for our products is technically complex, requiring high levels of quality control and precision, which subjects us to increased production risks.
  • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business, harm our reputation and impair our ability to provide our products on a timely basis or at all.
  • If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and supply our products and, as a result, there will be an adverse effect on our business until we are able to secure new facilities and rebuild our inventory.
  • Because we depend upon a limited number of third-party suppliers and manufacturers and, in certain cases, exclusive suppliers for products essential to our business, we may incur significant product development costs and experience material delivery delays if we lose any significant supplier, which could materially and adversely affect our business, financial condition and results of operations.
  • Certain of our products are dependent on the availability of tissue from human donors, and any disruption in supply could adversely affect our business, financial condition and results of operations.
  • Increased prices for raw materials used in our products could adversely affect our business, financial condition and results of operations.
  • If we are not able to accurately forecast demand for our products and manage our inventory, our margins could decrease and we could lose sales, either of which could have a material adverse effect on our business, financial condition and results of operations.
  • If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed with our products, it is unlikely our products will be widely used.
  • We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.
  • We bear the risk of warranty claims on our products.
  • Defects, failures or quality issues associated with our products could lead to product recalls or safety alerts, adverse regulatory actions, litigation, including product liability claims, and negative publicity, any of which may erode our competitive advantage and market share and have a material adverse effect on our reputation, business, financial condition and results of operations.
  • Our operating results may fluctuate significantly from quarter to quarter and year to year due to the seasonality of our business, as well as a variety of other factors, many of which are outside of our control.
  • Our indebtedness and our Revenue Interest Obligation to Ligand Pharmaceuticals Incorporated may limit our flexibility in operating our business and adversely affect our financial health and competitive position.
  • Our future capital needs are uncertain and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all.
  • Security breaches, loss of or damage to data, system failures and other disruptions could compromise sensitive information related to our business or our customers’ patients, or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • Our success depends on our ability to retain and motivate key management personnel and other employees and consultants, to attract, retain and motivate additional qualified personnel and to effectively navigate changes in our senior management team.
  • Our sales into foreign markets expose us to risks associated with international sales and operations.
  • We are subject to anti-bribery, anti-corruption and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, any of which would adversely affect our business, financial condition and results of operations.
  • Our officers, employees, independent contractors, principal investigators, consultants, commercial partners and independent sales agents may engage in misconduct or activities that are improper under other laws and regulations, which would create liability for us.
  • Our ability to use certain tax attributes to offset future income tax liabilities may be subject to limitations.
  • Changes in tax laws, unfavorable resolution of tax contingencies or exposure to additional income tax liabilities could have a material impact on our results of operations or financial condition.
  • As we conduct clinical studies designed to generate long-term data on some of our existing products, the data we generate may not be consistent with our existing data and may demonstrate less favorable safety or efficacy.
  • Our estimates of market opportunity and forecasts of market and sales growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.
  • The regulatory approval, certification and clearance processes of the FDA and comparable foreign authorities and notified bodies are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval or other marketing authorizations or certifications for our products and product candidates, our business will be substantially harmed.
  • Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • Modifications to our medical device products may require new 510(k) clearances or other marketing authorizations or certifications, and if we make modifications to such products without obtaining requisite marketing authorization, we may be required to cease marketing or recall the modified products until clearances or other marketing authorizations or certifications are obtained.
  • The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
  • Our HCT/P products are subject to extensive government regulation, and our failure to comply with these requirements could cause our business to suffer.
  • The clinical study process is lengthy and expensive with uncertain outcomes. We have limited data and experience regarding the safety and efficacy of our products. Results of earlier studies may not be predictive of future clinical study results, or the safety or efficacy profile for such products.
  • Disruptions at the FDA and other government agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared, certified or approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • We are subject to certain federal, state and foreign fraud and abuse laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
  • Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our cash flows, financial condition and results of operations.
  • Failure to comply with data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business.
  • If we are unable to obtain, maintain and adequately protect our intellectual property rights, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights.
  • We may not enter into invention assignment and confidentiality agreements with all of our employees and contractors and such agreements could be ineffective or breached.
  • The patent protection we obtain for our products may not be sufficient enough to provide us with any competitive advantage or our patents may be challenged.
  • Litigation or other proceedings or third-party claims of intellectual property infringement, misappropriation or other violations could require us to spend significant time and money, prevent us from selling our products and adversely affect our stock price.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
  • We may be unable to enforce our intellectual property rights throughout the world.
  • Third parties may assert ownership or commercial rights to inventions we develop.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Amendments and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed.
  • We depend on certain technologies that are licensed to us. We do not control the intellectual property rights covering these technologies, and any loss of our rights to these technologies or the rights licensed to us could prevent us from selling our products and adversely impact our business.
  • We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest, thereby harming our competitive position.
  • We expect that the price of our Class A common stock will fluctuate substantially and you may not be able to sell the shares you purchase at or above the price you paid for such shares.
  • Our principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.
  • A significant portion of our total outstanding shares are eligible to be sold into the market in the near future, which could cause the market price of our Class A common stock to drop significantly, even if our business is doing well.
  • The dual class structure of our common stock and the option of the holders of shares of our Class B common stock to convert into shares of our Class A common stock may limit your ability to influence corporate matters.
  • You may be diluted by the future issuance of additional common stock in connection with our incentive plans, acquisitions or otherwise.
  • We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
  • We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • Failure to comply with requirements to design, implement and maintain effective internal control over financial reporting could have a material adverse effect on our business and stock price.
  • Provisions in our certificate of incorporation and bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our certificate of incorporation designates specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, would be your sole source of gain.
  • We could be subject to securities class action litigation.
  • Uncertainty relating to the LIBOR calculation process and potential phasing out of LIBOR after 2021 may adversely affect the market value of our current or future debt obligations.
  • Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our business, financial condition and results of operations.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • If our operating and financial performance in any given period does not meet the guidance we provide to the public, the market price of our Class A common stock may decline.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our Class A common stock, our stock price and trading volume would likely decline.
Management Discussion
  • Net sales decreased $1.4 million, or 10.8%, to $11.5 million in the three months ended March 31, 2022 compared to $12.9 million in the three months ended March 31, 2021. The decline in net sales was due to reductions in the net sales of our Core Products of $2.5 million, partially offset by growth in the net sales of our Non-Core Products of $1.1 million.
  • Net sales generated by our Core Products declined $2.5 million, or 23.7%, to $8.1 million in the three months ended March 31, 2022 compared to $10.6 million in the three months ended March 31, 2021. The Core Products net sales reduction can be attributed to the cessation of purchases by Medtronic of FiberCel following our recall of a single lot of FiberCel in June 2021. Sales of FiberCel to Medtronic were $2.8 million in the three months ended March 31, 2021.
  • Net sales generated by our Non-Core Products increased $1.1 million, or 51.1%, to $3.4 million in the three months ended March 31, 2022 compared to $2.2 million in the three months ended March 31, 2021. The increase was primarily driven by a growth in the revenue from several contract manufacturing customers.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. freshman Avg
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